The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has announced regulatory flexibilities for certain medical devices. The appropriate notice has been published on the official website of the Federal Register.

According to the notice, the FDA intends to introduce permanent regulatory flexibilities to be applied during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus” in order to ensure and expand the availability of vitally important medical devices. In particular, the Agency plans to implement exemptions from premarket notification requirements for certain medical devices and is seeking feedback and suggestions in this regard. The document was developed by the Department of Health and Human Services (HHS).

Regulatory Background

According to the present document, the requirement to submit a 510(k) premarket notification could be waived for certain medical devices falling within the scope of the appropriate exemption, which covers Class I, Class II, and unclassified medical devices. The exempted devices would not be subject to mandatory premarket review prescribed under the general rule.

Medical device manufacturers and other parties involved in operations with medical devices are encouraged to submit their comments and suggestions regarding the proposed exclusion. In accordance with the procedure, all comments received will be published. 

It is important to note that, by virtue of the present document, the FDA:

  • Immediately introduces the exemption for 7 Class I medical devices, and 
  • Proposes the exemption for 84 Class II and unclassified medical devices. 

The FDA also refers to the US risk-based classification of medical devices, under which all medical devices are divided into three classes:

  • Class I devices, that present no unreasonable risk of illness or injury, and thus subject to general controls;
  • Class II devices, that are potentially more harmful than Class I devices and must comply with federal performance regulations known as “special controls,” and 
  • Class III devices carrying the highest risk, in that they are for “use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. 

Under the general rule, medical devices are subject to review by the regulating authority in two main forms: 

  1. Premarket approval (PMA) review to be applied in case of novel devices. This is the most detailed approach requiring the interested party to submit a wide range of information on the device in question, especially in terms of safety and efficacy.
  2. Premarket review process based on the demonstration of substantial equivalence to another medical device already placed on the market. This approach significantly reduces the regulatory burden for all parties involved. It also accelerates the procedures associated with placing new medical devices on the market while ensuring they meet the regulatory requirements on safety and effectiveness.

As stated by the Agency, the second pathway takes around 60 times less time than the first one, which requires much more time and resources. The document also provides the details on the expenses associated with each of the frameworks. The FDA states that in some cases, these expenses present unjustified barriers to entering the market. For this reason, the Agency intends to introduce a simplified approach designed to facilitate the review process. According to the document, the medical devices covered by the scope of an exemption to be introduced would no longer require a 510(k) premarket notification to be submitted. 

Premarket Notification Exemption

In order to ensure and expand the availability of vitally important medical devices during the pandemic, the FDA has already issued numerous guidance documents introducing special regulatory frameworks to be applied in the context of the COVID-19 outbreak. These frameworks prescribe special rules allowing medical devices to be placed on the market under simplified procedures. The same approach applies to modifications to the medical devices already placed on the market, provided that such modifications do not impact the safety and effectiveness of the devices when used for the intended purpose indicated by the manufacturer.

According to the position of the Agency, the suggested approach is justified in terms of benefit-risk balance associated with the flexibilities introduced – the clinical benefits from the expansion of the availability of medical devices outweigh the risks associated thereto. In particular, by virtue of the aforementioned guidance documents, the regulating authority explicitly states it is not going to object to the marketing and use of certain medical devices without the 510(k) clearance.

The document also describes the particular approach applied by the FDA when developing the present guidance and determining the medical devices subject to exemption prescribed herein. According to the document, the list of exempted medical devices is based on previous guidance documents issued by the FDA in the context of the pandemic.

Additional Regulatory Aspects

Another important aspect addressed in the document relates to the publicly available database containing information about the incidents and adverse events associated with medical devices. The Manufacturer and User Facility Device Experience database (MAUDE) contains mandatory reports submitted by medical devices manufacturers regarding products for which they are responsible. The FDA acknowledges that the information contained therein could be “incomplete, inaccurate, or biased.” However, as of today, this database remains a source of data to be used by parties involved. By using the database, one can find information regarding adverse events associated with a particular type of medical device by using the three-letter product code. This could be used to obtain data on the performance of medical devices, and adverse events associate thereto in a structured way. The number of reports related to medical devices has been one of the criteria considered by the Agency when determining the scope of products subject to the exemption.

The document also contains an exhaustive list of medical devices for which the requirement on the submission of a 510(k) premarket notification could be waived, including the device description, the class of the device under the risk-based classification, the appropriate product code, and also reference to applicable regulation (section in 21 CFR).

In summary, the present FDA notice describes the approach the regulating authority intends to introduce in order to streamline and facilitate the procedures associated with placing new medical devices on the market. In particular, the Agency intends to implement additional flexibilities and waive some of the requirements for certain medical devices that are vitally important in the context of the pandemic.

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